SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifier
Trade name:Infliximab Formulation - (OGN)

1.2 Relevant identified uses of the substance or mixture and uses advised against
Use of the Sub: Pharmaceuticalstance/Mixture
Recommended restrictions
on use:Not applicable

1.3 Details of the supplier of the safety data sheet
Company: Organon & Co.
Shotton Lane
NE23 3JU Cramlington NU - Great Britain
Telephone:+44 1 670 59 32 05

E-mail address of person
responsible for the SDS:

EHSSTEWARD@organon.com

1.4 Emergency telephone number+1-215-631-6999

SECTION 2: Hazards identification
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK
SI 2019/720, and UK SI 2020/1567)
Not a hazardous substance or mixture.
2.2 Label elements
Labelling (REGULATION (EC) No 1272/2008) as amended by GB-CLP Regulation, UK SI
2019/720, and UK SI 2020/1567)
No hazard pictogram, no signal word, no hazard statement(s), no precautionary statement(s) required
EUH210

Safety data sheet available on request.

1 / 13

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

2.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% orhigher.
Dust contact with the eyes can lead to mechanical irritation.
Contact with dust can cause mechanical irritation or drying of the skin.
May form explosive dust-air mixture during processing, handling or other means.

SECTION 3: Composition/information on ingredients
3.2 Mixtures
Components
Chemical name

CAS-No.
EC-No.
Index-No.
Registration number
170277-31-3

Infliximab

Classification

Substances with a workplace exposure limit :Sucrose57-50-1
200-334-9

Concentration(% w/w)>= 10 - < 20>= 70 - < 90

For explanation of abbreviations see section 16.

SECTION 4: First aid measures
4.1 Description of first aid measures
General advice: In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
Protection of first-aiders:

No special precautions are necessary for first aid responders.

If inhaled:

If inhaled, remove to fresh air.
Get medical attention if symptoms occur.

In case of skin contact:

Wash with water and soap.
Get medical attention if symptoms occur.

In case of eye contact:

If in eyes, rinse well with water.
Get medical attention if irritation develops and persists.

If swallowed:

If swallowed, DO NOT induce vomiting.
Get medical attention if symptoms occur.
Rinse mouth thoroughly with water.

4.2 Most important symptoms and effects, both acute and delayed
Risks: Contact with dust can cause mechanical irritation or drying of
2 / 13

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

the skin.
Dust contact with the eyes can lead to mechanical irritation.
4.3 Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.

SECTION 5: Firefighting measures
5.1 Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical:

None known.

5.2 Special hazards arising from the substance or mixture
Specific hazards during fire- : Avoid generating dust; fine dust dispersed in air in sufficient
fighting
concentrations, and in the presence of an ignition source is apotential dust explosion hazard.
Exposure to combustion products may be a hazard to health.
Hazardous combustion products
5.3 Advice for firefighters
Special protective equipment
for firefighters
Specific extinguishing methods:

Carbon oxides:

Wear self-contained breathing apparatus for firefighting if necessary. Use personal protective equipment.

:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.

SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Personal precautions: Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).
6.2 Environmental precautions
Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Retain and dispose of contaminated wash water.
If spillage enters rivers or watercourses, inform the Environ3 / 13

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

ment Agency (emergency telephone number 0800 807060).
6.3 Methods and material for containment and cleaning up
Methods for cleaning up: Sweep up or vacuum up spillage and collect in suitable container for disposal.
Avoid dispersal of dust in the air (i.e., clearing dust surfaces
with compressed air).
Dust deposits should not be allowed to accumulate on surfaces, as these may form an explosive mixture if they are released into the atmosphere in sufficient concentration.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.
6.4 Reference to other sections
See sections: 7, 8, 11, 12 and 13.

SECTION 7: Handling and storage
7.1 Precautions for safe handlingTechnical measures:

Local/Total ventilation
Advice on safe handling::

Hygiene measures:

Static electricity may accumulate and ignite suspended dust
causing an explosion.
Provide adequate precautions, such as electrical grounding
and bonding, or inert atmospheres.
Use only with adequate ventilation.
Do not breathe dust.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Minimize dust generation and accumulation.
Keep container closed when not in use.
Keep away from heat and sources of ignition.
Take precautionary measures against static discharges.
Take care to prevent spills, waste and minimize release to theenvironment.
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place. When using do not eat, drink or smoke. Wash contaminated clothing before re-use.

7.2 Conditions for safe storage, including any incompatibilities
Requirements for storage: Keep in properly labelled containers. Store in accordance withareas and containers
the particular national regulations.
Advice on common storage:

Do not store with the following product types:
Strong oxidizing agents

7.3 Specific end use(s)4 / 13

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Specific use(s):Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

No data available
No data available

SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure Limits
dust of any kind
10 mg/m3
Value type (Form of exposure): TWA (Inhalable)
Basis: GB EH40
4 mg/m3
Value type (Form of exposure): TWA (Respirable fraction)
Basis: GB EH40
Components

CAS-No.

Sucrose57-50-1

Infliximab

170277-313

Value type (Formof exposure)
TWA
STEL
TWA

Control parameters

Basis

10 mg/m3
20 mg/m3
150 µg/m3

GB EH40
GB EH40
Internal

8.2 Exposure controls
Engineering measures
Ensure adequate ventilation, especially in confined areas.
Minimize workplace exposure concentrations.
Apply measures to prevent dust explosions.
Ensure that dust-handling systems (such as exhaust ducts, dust collectors, vessels, and processing equipment) are designed in a manner to prevent the escape of dust into the work area
(i.e., there is no leakage from the equipment).
Personal protective equipment
Eye/face protection: Wear the following personal protective equipment:
Safety goggles
Equipment should conform to BS EN 166
Hand protection
Material:

Chemical-resistant gloves

Remarks:

For prolonged or repeated contact use protective gloves.
Wash hands before breaks and at the end of workday.
Skin should be washed after contact.
If adequate local exhaust ventilation is not available or exposure assessment demonstrates exposures outside the recommended guidelines, use respiratory protection.
Equipment should conform to BS EN 143
Particulates type (P)Skin and body protection
Respiratory protection

Filter type:::

5 / 13

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Appearance: Amorphous powder
Colour: whiteOdour: No data available
Odour Threshold: No data available
pH

:

7.2

Melting point/freezing point:

No data available

Initial boiling point and boiling
range
Flash point:

No data available:

No data available

Evaporation rate:

No data available

Flammability (solid, gas):

May form explosive dust-air mixture during processing, handling or other means.

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:

No data available

Relative vapour density:

No data available

Relative density:

No data available

Density:

1 g/cm³::

No data available
No data available:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Solubility(ies)
Water solubility
Partition coefficient: noctanol/water
Auto-ignition temperature

9.2 Other information
6 / 13

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Flammability (liquids):

No data available

Molecular weight:

No data available

Particle size:

No data available

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

SECTION 10: Stability and reactivity
10.1 Reactivity
Not classified as a reactivity hazard.
10.2 Chemical stability
Stable under normal conditions.
10.3 Possibility of hazardous reactions
Hazardous reactions: May form explosive dust-air mixture during processing, handling or other means.
Can react with strong oxidizing agents.
10.4 Conditions to avoid
Conditions to avoid:

Heat, flames and sparks.
Avoid dust formation.

10.5 Incompatible materials
Materials to avoid:

Oxidizing agents

10.6 Hazardous decomposition products
No hazardous decomposition products are known.

SECTION 11: Toxicological information
11.1 Information on toxicological effects
Information on likely routes of : Inhalation
exposure
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Components:
Sucrose:Acute oral toxicity:

LD50 (Rat): 29,700 mg/kg

Skin corrosion/irritation
Not classified based on available information.

7 / 13

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

Components:
Infliximab:
Remarks:

No data available

Serious eye damage/eye irritation
Not classified based on available information.
Components:
Infliximab:
Remarks:

No data available

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.
Germ cell mutagenicity
Not classified based on available information.
Components:
Infliximab:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Method: OECD Test Guideline 471
Result: negative
Test Type: Chromosomal aberration
Test system: human lymphoblastoid cells
Result: negative

Genotoxicity in vivo:

Test Type: Micronucleus test
Species: Mouse
Method: OECD Test Guideline 474
Result: negative

Germ cell mutagenicity- Assessment:

Weight of evidence does not support classification as a germ
cell mutagen.

:

Test Type: In vitro mammalian cell gene mutation test
Result: negative

Sucrose:Genotoxicity in vitro

Carcinogenicity
Not classified based on available information.
Reproductive toxicity
Not classified based on available information.
8 / 13

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

Components:
Infliximab:
Effects on fertility

Effects on foetal development:

Test Type: Fertility
Species: Mouse
Application Route: Intravenous injection
Fertility: NOAEL: 40 mg/kg body weight
Remarks: Based on data from similar materials:

Test Type: Embryo-foetal development
Species: Mouse, female
Application Route: Intravenous injection
Duration of Single Treatment: 6 - 12 dGeneral Toxicity Maternal: NOAEL: 40 mg/kg body weight
Teratogenicity: NOAEL F1: 40 mg/kg body weight
Developmental Toxicity: NOAEL F1: 40
Embryo-foetal toxicity: NOAEL: 40 mg/kg body weight
Remarks: Based on data from similar materials

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Not classified based on available information.
Repeated dose toxicity
Components:
Infliximab:Species
NOAEL
Application RouteExposure time
Number of exposures

:
:
:
:
:

Mouse
40 mg/kg
Intravenous
6 Monthsdaily

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Infliximab:
Inhalation:

Symptoms: Nausea, Vomiting, Abdominal pain, Diarrhoea,
Fatigue, Headache, Back pain

9 / 13

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

SECTION 12: Ecological information
12.1 Toxicity
Components:
Infliximab:
Ecotoxicology Assessment
Acute aquatic toxicity:

No data available

Chronic aquatic toxicity

No data available:

12.2 Persistence and degradability
No data available
12.3 Bioaccumulative potential
Components:
Sucrose:Partition coefficient: noctanol/water:

Pow: < 1

12.4 Mobility in soil
No data available
12.5 Results of PBT and vPvB assessment
Product:
Assessment:

This substance/mixture contains no components considered
to be either persistent, bioaccumulative and toxic (PBT), orvery persistent and very bioaccumulative (vPvB) at levels of
0.1% or higher.

:

This substance/mixture does not contain components considered to have endocrine disrupting properties for environment
according to UK REACH Article 57(f).

12.6 Other adverse effects
Product:
Endocrine disrupting potential

SECTION 13: Disposal considerations
13.1 Waste treatment methods
Product:

Dispose of in accordance with local regulations.
According to the European Waste Catalogue, Waste Codes
are not product specific, but application specific.
Waste codes should be assigned by the user, preferably in
discussion with the waste disposal authorities.
Do not dispose of waste into sewer.
10 / 13SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

Contaminated packaging

SDS Number:
9883009-00007:

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

SECTION 14: Transport information
14.1 UN number
ADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA

:

Not regulated as a dangerous goodADN:

Not regulated as a dangerous goodADR:

Not regulated as a dangerous goodRID:

Not regulated as a dangerous good

IMDG

:

Not regulated as a dangerous good

IATA (Cargo):

Not regulated as a dangerous good

IATA (Passenger):

Not regulated as a dangerous good

14.2 UN proper shipping name14.3 Transport hazard class(es)14.4 Packing group

14.5 Environmental hazards
Not regulated as a dangerous good
14.6 Special precautions for user
Not applicable
14.7 Transport in bulk according to Annex II of Marpol and the IBC CodeRemarks: Not applicable for product as supplied.
11 / 13SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
Relevant EU provisions transposed through retained EU law
UK REACH List of restrictions (Annex 17): Not applicable
UK REACH Candidate list of substances of very high: Not applicableconcern (SVHC) for Authorisation
The Persistent Organic Pollutants Regulations (retained : Not applicable
Regulation (EU) 2019/1021 as amended for Great Britain)
Regulation (EC) No 1005/2009 on substances that de: Not applicableplete the ozone layer
UK REACH List of substances subject to authorisation: Not applicable(Annex XIV)GB Export and import of hazardous chemicals - Prior: Not applicable
Informed Consent (PIC) Regulation
Control of Major Accident Hazards Regulations 2015 (COMAH)
Not applicable
The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined15.2 Chemical safety assessment
A Chemical Safety Assessment has not been carried out.

SECTION 16: Other information
Other information:

Items where changes have been made to the previous version
are highlighted in the body of this document by two verticallines.

Full text of other abbreviations
GB EH40: UK. EH40 WEL - Workplace Exposure Limits
GB EH40 / TWA: Long-term exposure limit (8-hour TWA reference period)
GB EH40 / STEL
: Short-term exposure limit (15-minute reference period)
ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - Agreement concerning the International Carriage of Dangerous Goods by
Road; AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standardof the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECHA European Chemicals Agency; EC-Number - European Community number; ECx - Concentration
associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergen12 / 13

SAFETY DATA SHEET
According to REACH Regulation (EC) No 1907/2006, as amended by
UK REACH Regulations SI 2019/758

Infliximab Formulation - (OGN)
Version
4.2

Revision Date:
06.04.2024

SDS Number:
9883009-00007

Date of last issue: 30.09.2023
Date of first issue: 19.10.2021

cy Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rate response; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - International Air
Transport Association; IBC - International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China;
IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL
- Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization;
KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified;NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NZIoC - New Zealand Inventory ofChemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RID - Regulations concerning the International Carriage of Dangerous
Goods by Rail; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet;
SVHC - Substance of very high concern; TCSI - Taiwan Chemical Substance Inventory; TECI Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN- United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous
Goods; vPvB - Very Persistent and Very Bioaccumulative
Further information
Sources of key data used tocompile the Safety Data
Sheet

:

Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
GB / EN

13 / 13